Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV. (HOPE II)

Mass General Brigham

Status and phase: Active, not recruiting; Phase 4

Conditions: Human Papilloma Virus; Hiv

Treatments: Biological: GARDASIL®9; Biological: Menveo®/Menactra®

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06436274

2024P000880

Details and patient eligibility

About

The Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living with HIV: A Prospective, Individual, Double-Blind, Randomized Controlled Study is evaluating immediate or delayed single-dose nonavalent HPV vaccination among women living with HIV who received prior HPV vaccination.

Full description

The HOPE II Study is an individual-level, randomized trial of immediate or delayed vaccination with a single-dose of the nonavalent HPV vaccine. The primary outcome is single-dose HPV 16/18/31/33/45/52/58 vaccine efficacy (VE). The study will provide evidence on the efficacy of single-dose HPV 16/18/31/33/45/52/58 vaccination among women living with HIV.

Participants will be randomized 1:1 into two different Groups.

• Group 1: Will receive nonavalent HPV vaccine at Day 0 and meningococcal vaccine at Month 18
• Group 2: Will receive the meningococcal vaccine at Day 0 and nonavalent HPV at Month 18

The meningococcal vaccine was chosen as the control vaccination because meningococcal vaccination has no activity against HPV infection. Further, the meningococcal vaccine has the potential to be of benefit in a meningitis outbreak context and could be beneficial for young persons in a congregate setting such as tertiary institutions.

Enrollment: 778 patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 16 years and above on the day of signing the ICF
2. Living with HIV with confirmed test results or clinic records
3. History of receiving HPV vaccine
4. Self-reported sexually active in the last six months
5. Lives within the study area and willing to provide updated locator information over the course of the study
6. Does not have an autoimmune, degenerative, or genetic disease
7. Does not have known advanced HIV (as per stage IV WHO clinical staging criteria for HIV)
8. No other Investigator-determined factor would limit participation in the trial
9. Has not and is not enrolled in a monoclonal, investigational vaccine, or a large quantity blood draw study
10. The participant has a cervix

Exclusion criteria

1. Anyone with cervical abnormality on examination
2. Anyone with an allergy to vaccine components or yeast

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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778 participants in 2 patient groups

Group 1

Experimental group

Description:

Will receive GARDASIL®9 vaccine at Day 0 and Menveo®/Menactra® vaccine at Month 18

Treatment:

Biological: Menveo®/Menactra®

Biological: GARDASIL®9

Group 2

Active Comparator group

Description:

Will receive the Menveo®/Menactra® vaccine at Day 0 and GARDASIL®9 at Month 18

Treatment:

Biological: Menveo®/Menactra®

Biological: GARDASIL®9